Myopia
Conditions
Brief summary
The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.
Interventions
DEVICELotrafilcon A Experimental Contact Lens
Experimental spherical, silicone hydrogel soft contact lens
DEVICELotrafilcon A Commercial Contact Lens
Commercially marketed spherical, silicone hydrogel soft contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day * On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses * Other protocol-defined inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Vision | 1 week | Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent. |
Participant flow
Pre-assignment details
One participant was enrolled but not dispensed due to failing inclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Contact Lens / Commercial Contact Lens Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear. | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | Experimental Contact Lens / Commercial Contact Lens |
|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Overall Vision
Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time frame: 1 week
Population: Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lotrafilcon A Commercial Contact Lens | Overall Vision | 8.7 Units on a Scale | Standard Deviation 1.5 |
| Lotrafilcon A Experimental Contact Lens | Overall Vision | 8.7 Units on a Scale | Standard Deviation 1.7 |